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Cholinesterase Inhibitor

GB-5001 for Alzheimer's Disease

Phase 1

Waitlist Available

Research Sponsored by G2GBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 64

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new medicine for healthy male volunteers. Results will help predict how the drug works in multiple doses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Electrocardiograms

Incidence, severity, and dose-relationship of AEs

Injection site assessments

+2 more

Secondary outcome measures

Key PK parameters for single dose IM and Oral cohorts

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: GB-5001Experimental Treatment1 Intervention

GB-5001 Suspension for intramuscular (IM) injection at three doses

Group II: Oral cohortActive Control1 Intervention

Aricept® tablet

Group III: PlaceboPlacebo Group1 Intervention

Placebo Suspension for intramuscular (IM) injection, Volume to be matched with the active drug in the respective cohort

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GB-5001

2022

Completed Phase 1

~50

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

G2GBio, Inc.Lead Sponsor

2 Previous Clinical Trials

86 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for me to join this clinical investigation?

"Those suffering from Alzheimer's and between the ages of 18 to 55 may be eligible for this trial. We are seeking approximately 48 participants in total."

Answered by AI

What is the aggregate of participants signing up for this experiment?

"Correct. According to the clinicaltrials.gov website, this medical trial is currently seeking participants after being first published on August 26th 2022 and updated recently on November 9th 2022. The research requires 48 patients from a single site for successful completion."

Answered by AI

Are octogenarians allowed to partake in this research trial?

"This trial only accepts applicants aged between 18 and 55. For younger individuals, there are 23 trials available and for those over 65, 536 opportunities exist."

Answered by AI

Is there still an opportunity for individuals to participate in this research?

"According to the clinicaltrials.gov data, this trial is in a state of active recruitment since its initial posting on August 26th 2022 and subsequent update on November 9th 2022."

Answered by AI

What potential risks do patients face when administered GB-5001?

"As this is an early stage trial, the safety of GB-5001 was assessed to be a 1 on our rating scale. This grade reflects limited data supporting efficacy and only preliminary evidence indicating its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers

2022. "Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525780.